Practical application of SAS® Clinical Data Integration Server for conversion to SDTM data

Conversion of legacy clinical data into a standardized data model consists of different steps from annotating the CRF, preparing the mapping into the CDISC SDTM model to producing metadata reports and CRT-DDS (define.xml). In order to accelerate the conversion process, we have used the SAS® Clinical Data Integration Server framework, which has been designed to help life sciences organizations visually design conversion processes driven by standardized metadata. We will discuss in this paper our implementation approach and how SAS® Clinical Data Integration Server significantly shortened our throughput time needed to produce SDTM-compliant submission-ready packages. In addition, extensive compliancy and quality control checks ensure that the data and metadata is consistent and according to the defined standards.